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Class III · Lower riskRecall completed

Orphenadrine Citrate

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot # DM1316; Exp. 05/16 Lot # DM1318; Exp. 05/16
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySandoz Inc., Princeton, NJ 08540
Brand nameORPHENADRINE CITRATE
Generic nameORPHENADRINE CITRATE
Active ingredient(s)ORPHENADRINE CITRATE
Distributed by / forSandoz Inc
NDC0185-0022-01
Show the full FDA record
Full product labelOrphenadrine Citrate Extended Release Tablets, 100 mg a)100-count bottle, (NDC 0185-0022-01) b) 1000-count bottle, (NDC 0185-0022-10), Rx only, Manufactured by Sandoz Inc., Princeton, NJ 08540.
Recalling firmSandoz Inc
DistributionNationwide
Quantity781,000 extended release tablets
Recall initiated2014-07-11
Report date2014-07-30
Recall completed2017-07-10
Recall numberD-1445-2014
ClassificationClass III
FDA statusTerminated
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.